Principal Quality Engineer, Design Assurance (Medical Devices)

Johnson & Johnson Co.; New Brighton (MN); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson in New Brighton, MN seeks a Principal Quality Engineer (Design Assurance) to lead quality activities for medical devices. You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to drive design assurance, risk management, and V&V across programs.

The role requires 10+ years in medical devices (or 8+ with a Master's). Strong knowledge of ISO 13485, ISO 14971, FDA QMSR, and 21 CFR 820 is essential.

Qualifications

• A Bachelor's or Master's in Biomedical/Mechanical Engineering with extensive medical device experience.
• Experience applying ISO 13485, ISO 14971, 21 CFR 820 and IVD/CE requirements in design.
• Proven ability to lead complex V&V, DHF management, TMV, and regulatory audits.

Responsibilities

• Lead quality assurance for new product development.
• Ensure ISO 13485 compliance and regulatory alignment across programs.
• Provide mentoring and design assurance guidance to senior engineers.
• Review and approve protocols, tests, and reports.
• Manage risk analyses (FMEA) and risk control strategies.
• Support design transfer, V&V oversight, and supplier quality activities.

Skills

Coaching

Controls Compliance

Critical Thinking

Engineering

Fact‑Based Decision Making

Quality Systems Documentation

Quality Validation

ISO 9001

Statistical Methods

Test Design

Education

BSc/Bachelor in Biomedical/Mechanical Engineering or related

MS in Engineering (preferred)

Tools

Minitab

Windchill PLM

Job description

Johnson & Johnson in New Brighton, MN seeks a Principal Quality Engineer (Design Assurance) to lead quality activities for medical devices. You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to drive design assurance, risk management, and V&V across programs.

The role requires 10+ years in medical devices (or 8+ with a Master's). Strong knowledge of ISO 13485, ISO 14971, FDA QMSR, and 21 CFR 820 is essential.